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A new ASTM International standard will help medical device manufacturers collect sufficient data to demonstrate that they consistently clean medical devices to a safe and effective level. The new standard (soon to be published as F3127 , Guide for Validating Cleaning Lines for Medical Devices) is the result of a November 2011 symposium sponsored by ASTM on Cleaning Validation of Medical Devices.…, ASTM Committee F04 on Medical and Surgical Materials and Devices Next Meeting:, May 3-5, 2016, May Committee Week, Media Inquiries:, Dan Bergels, tel +1.610.832.9602; dbergels@astm.org, Technical Contact:, Randall J. Thoma, Ph.D., VeeSquared Consulting Services, Round Rock, Texas, tel +1.512.924.3832; randy.thoma@VeeSquared.com, ASTM Staff Contact:, Pat Picariello, tel +1.610.832.9720; ppicariello@astm.org Release #10050
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ASTM International’s Committee D09 (Electrical and Electronic Insulating Materials) invites anyone to join in developing a new standard to help maintain the integrity of cables during an emergency such as a fire. Specifically, the proposed standard (WK52230, Test Method for Determination of Acid Gas Content of Wire and Cable Insulation or Jacket Material) will help determine the halogen content…, ASTM Committee D09 Next Meeting:, April 14-15, 2016, April Committee Week, San Antonio, Texas, Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Larry Ingram, Williamsport, Pa., tel +1.570.916.8448; larry77151@comcast.net , ASTM Staff Contact:, Katerina Koperna, tel +1.610.832.9728; kkoperna@astm.org Release #9960
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ASTM International has published a new test method for measuring the oxygen transmission rate through plastic packaging for food, pharmaceuticals and other products. The standard ( F3136 , Test Method for Oxygen Gas Transmission Rate through Plastic Film and Sheeting Using a Dynamic Accumulation Method) covers film, sheeting, laminates, coextrusions and coated or uncoated papers or fabrics.…, ASTM Committee F02 on Flexible Barrier Packaging Next Meeting:, Oct. 28-29, 2015, October Committee Week, Tampa, Fla., Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Nick Winters, Harbor Associates LLC, Avalon, N.J., tel +1.914.393.8343; harborassociates@verizon.net , ASTM Staff Contact:, Diane Lake, tel +1.610.832.9661; dlake@astm.org Release #9890
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ASTM International Committee F02 on Flexible Barrier Packaging is developing a new standard to test the transmission rate of water vapor into packaging materials. Understanding water transmission rate is a key component for the shelf life of many products. “The materials and packages covered by this standard affect nearly every package one sees in grocery stores, pharmacies and hospitals,” says…, ASTM Committee F02 Next Meeting:, Oct. 28-29, 2015, October Committee Week, Tampa, Fla., Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, Technical Contact:, Joel Fischer, MOCON Laboratory, tel +1.763.493.7219; jfischer@mocon.com, ASTM Staff Contact:, Diane Lake, tel +1.610.832.9661; dlake@astm.org Release #9822 ###
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ASTM International and the Parenteral Drug Association recently signed a Memorandum of Understanding that launches a pilot to streamline efforts and conserve resources as both organizations develop technical guidance for the pharmaceutical industry. Katharine Morgan, executive vice president, ASTM, and Richard M. Johnson, president, PDA, signed the MOU. “The MOU between ASTM International and PDA…, ASTM Committee E55 on Manufacture of Pharmaceutical Products Next Meeting:, April 28-30, 2015, Lisbon, Portugal, Media Inquiries:, Nathan Osburn, tel +1.610.832.9603; nosburn@astm.org, ASTM Staff Contact:, Christine DeJong, tel +1.610.832.9736; cdejong@astm.org Release #9815 ###
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Proper packaging procedures are an important aspect of any industry. Now ASTM International Committee F02 on Flexible Barrier Packaging has developed a standard for a relatively new packaging technology, airborne ultrasound. ASTM F3004 , Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound, was developed by Subcommittee F02.40 on Package Integrity . “Airborne…, ASTM Committee F02 Next Meeting:, April 7-9, 2014, Lansing, Mich., Technical Contact:, Oliver Stauffer, PTI Inspection Systems, Tuckahoe, N.Y., Phone: 914-337-2005; o.stauffer@ptiusa.com , ASTM Staff Contact:, Diane Trinsey, Phone: 610-832-9661; dtrinsey@astm.org , ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9566
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, ASTM to Partner with ASC to Foster EPD Development, ASTM International will be collaborating with industry to develop Environmental Product Declarations (EPDs) across the 90+ industry markets they support, including sealants. The Adhesive and Sealant Council (ASC) will be partnering with ASTM International to raise awareness of this effort, educate industry on the value of Type III EPDs, and proactively engage industry in developing Product…, ASTM Staff Contact:, Tim Brooke, Phone: 610-832-9729; tbrooke@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9370
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ASTM International Committee E55 on Manufacture of Pharmaceutical Products is currently developing a proposed standard that will document a set of process steps that can reproducibly inactivate or remove any potential retrovirus in new biological products, particularly antibodies and antibody-like compounds. The proposed standard, ASTM WK39883 , Practice for Process of Inactivation of Enveloped…, ASTM Committee E55 Next Meeting:, April 9-11, 2013, Genzyme-A Sanofi Company, Haverhill, Suffolk, United Kingdom, Technical Contact:, John Schreffler, Ph.D., Morphotek Inc., Exton, Pa., Phone: 610-423-6557; jschreffler@morphotek.com, ASTM Staff Contact:, Christine DeJong, Phone: 610-832-9736; cdejong@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #9327
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ASTM International Committee F02 on Flexible Barrier Packaging will hold its next meeting on Sept. 26-27, 2012, at the Hotel Rey Juan Carlos I in Barcelona, Spain. At this meeting, participants will have the opportunity to contribute to the development and revision of a number of standards important to the use and evaluation of flexible barrier packaging. One of the highlights of the meeting will…, Future Trends in Permeation Measurements, , presented by Franz Sturm, Lipke •, U.S. FDA Perspective: The Use of Standards in Premarket Submissions and Auditing the Medical Device Packaging Process, , presented by Pat Weixel, U.S. Food and Drug Administration •, Microbial Barrier Test Methods for Porous Sterile Barrier Materials, , presented by Thierry Wagner, DuPont Medical and Pharmaceutical Protection •, Toward a Package Durability Predictive Model, , presented by Henk Blom, Rollprint Packaging Products •, Package Integrity: Methods of Detection, , presented by Wendy Mach, Nelson Laboratories •, Use of Design Guide F2097 and U.S. FDA Recognition, , Hal Miller, PACE Solutions LLC •, Sterile Medical Device Package Performance Testing and the Nebulous Effect of Vibration in Transit, , presented by Pat Nolan, DDL •, ASTM International: ASTM Mechanics and Overview, , presented by Diane Trinsey, ASTM Committee F02 staff manager All are welcome to attend. Registration and meeting information, including abstracts describing the presentations shown above, can be found at www.astm.org/COMMIT/F02/Barcelona_Meeting_info . Committee F02 develops standards on barrier materials, their properties and package design, development and production. Typical flexible barrier…, ASTM Committee F02 Next Meeting:, Sept. 26-27, 2012, Barcelona, Spain, ASTM Staff Contact:, Diane Trinsey, Phone: 610-832-9661; dtrinsey@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org R elease #9289
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A proposed new ASTM International standard will provide an important process step to be used in the manufacture of protein-based drugs, such as antibodies and fusion proteins, made to inactivate retroviruses. The proposed standard, ASTM WK36552 , Practice for Inactivation of Retrovirus by pH, is being developed by Subcommittee E55.04 on General Biopharmaceutical Standards , part of ASTM…